Faculty Researchers and Innovators: What you need to know about IRBs and the medtech innovation process – Insights & Recording

New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by regulatory agencies responsible for safety and efficacy. As far as those regulatory bodies are concerned, the path to clinical trials in humans is the same whether it’s research or commercial driven. Failing to walk that…

Demand, Logistics, Technologies and Lifecycle Services: The State of Bioskills Training and Education

Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed . Teams leaned on virtual engagement technologies, dedicated lab staff, and proctors onsite, to deliver the training and education required to learn how to safely employ new technologies, products and techniques. At the importance of…

The State of Preclinical Studies: A Q&A with GCMI’s Director of Scientific Affairs Evan Goldberg

Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…

Why GCMI for your medtech design & development needs? We have established a proven, capital-efficient pathway and process.

A medtech or life science project’s success is dependent on the careful consideration of several intersecting components: technological, clinical, commercial and legal. GCMI follows a structured, phase-gated process that allows for a disciplined, capital efficient medical device design and product development approach.

Attacking the Challenges of Achalasia: GT Capstone’s “G.I. (Mostly) Joes”

“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in tissue that closely mimics live human tissue… in a safe environment for live tissue where sanitation would not be a concern. The GCMI and T3 Labs team helped prepare the space, tools, and specimen we needed for the validation testing event.”

Dr. Emily Blum, Medical Affairs Liaison for GCMI, Named Emory University Adjunct Assistant Professor

Congratulations to GCMI’s very own: Dr. Emily Blum on her recent advancement within Emory University from Adjunct Clinical Instructor to Adjunct Assistant Professor. The advancement is a testament to Dr. Blum’s commitment to education and clinical research. Emily is instrumental in advancing med tech innovation for GCMI. She works tirelessly to promote GCMI in successfully…

Why GCMI for preclinical testing and bioskills training? Commitment to value.

We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study is the one you have to do twice.   Our response to your request for preclinical work may not be the lowest bottom line price. But please know this: all…

Why GCMI for preclinical testing and bioskills training? Our scientific acumen.

At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed by translational researchers for medical product developers. Thirst for science: it’s in our DNA.    We won’t turn your project away because it’s too hard, or because we haven’t done…

Why GCMI for preclinical testing and bioskills training? Quality, compliance and accreditation.

At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers.   GCMI is committed to working with innovators to test medical technologies and therapeutics that consistently meet customer needs and regulatory requirements. We maintain Quality Management Systems to ensure compliance and ongoing quality of our deliverables, products and services.…